Stockholm3 in NICE Medtech Innovation Briefing for the UK
August 23, 2022
NICE, the UK National Institute for Health and Care Excellence, has published a Medtech Innovation Briefing (MIB) on Stockholm3, where experts state that Stockholm3 has the potential of improving accuracy in prostate cancer diagnostics. The MIB report is not a recommendation, but generally seen as a first step towards diagnostic guidance in the UK.
NICE has been evaluating Stockholm3 as a means of improving prostate cancer diagnostics in the UK. The outcome of the evaluation is a MIB report providing a thorough external evaluation of Stockholm3, including comments by independent NICE experts and patient organization representatives.
The report highlights that the improved accuracy of Stockholm3 has the potential to reduce unnecessary MRIs and biopsies and that implementation of Stockholm3 could potentially reduce the overall costs of prostate cancer diagnosis in the UK. The clinical evidence is described as “adequate and of good methodological quality”. However, the report mentioned the lack of studies carried out in the UK, and the lack of data on non-Caucasian ethnicities, which are currently in progress.
Several of the experts noted that the use of Stockholm3 could lead to less or similar resource usage compared with current standards of care. A representative from the patient organization Prostate Cancer UK said that ”the benefits of Stockholm3 are that it is convenient and results in quick and accurate care provision” and that “Stockholm3 prevents harm from unnecessary biopsies. For people who are concerned about their prostate cancer risk, this technology could rule out any unnecessary worry of being referred into secondary care for an exploratory MRI scan or biopsy.”
“The MIB report is a great initial step for us in the UK. Even though it is not a diagnostic guidance, it shows that the specific benefits of Stockholm3 are understood and appreciated. We are already conducting studies on non-Caucasian ethnicities, and we are planning to start a validation study in the UK”, says David Rosén, CEO of A3P Biomedical.
“While we realize that a diagnostic guidance from NICE will take more time, we can now start contacting private and NHS care providers, based on the findings of this report”, David Rosén concludes.
With more than 52,000 new cases per year, prostate cancer is the most common form of cancer in UK men and one of the deadliest with 12,000 fatalities every year.
About A3P Biomedical
A3P Biomedical is a company that specializes in advanced prostate cancer diagnostics. A3P’s main product, Stockholm3, is a clinically and commercially validated blood test for early detection and risk stratification of aggressive prostate cancer. A3P Biomedical is headquartered in Stockholm, Sweden. For more information, please visit www.a3p.com
About Stockholm3
Stockholm3 is a blood-based test, that runs a combination of protein biomarkers, genetic biomarkers and clinical information through an algorithm to find the probability of clinically significant cancer at biopsy.
Stockholm3 has been evaluated in clinical studies including more than 90,000 men. It is extensively tested in large population-based screening trials, as well as in real world clinical utility studies in primary care, as a reflex test to PSA at values 1.5-20 ng/ml. Benefits include the ability to reduce unnecessary MRIs, benign and Grade Group 1 prostate biopsies for men with elevated PSA, while simultaneously improving detection of clinically significant cancers in men with low or normal PSA values. Using Stockholm3 leads to a more accurate risk assessment than the current PSA standard. Stockholm3 detects 40-90% more men with aggressive prostate cancer and, at the same time, reduces over-detection by 40-50% compared to PSA.
Multiple Stockholm3 studies have been published in high-impact journals such as The Lancet Oncology, Journal of Clinical Oncology, and European Urology. The studies address both the specificity and sensitivity of Stockholm3 in multi-ethnic populations as well as health-economic benefits of implementing it in clinical care. For more information about our clinical studies please visit www.a3p.com.
About prostate cancer
Prostate cancer is the most common cancer in men. In 2020, the global incidence of new prostate cancer cases was 1.4 million, and prostate cancer specific mortality 370,000. Global prostate cancer incidence and mortality is expected to rise by 100% and 85% respectively by 2040, driven by an ageing population.
Press contact:
Cecilia Edström
cecilia.edstrom@a3p.com
+46 72 226 2328